Effect of Holofiber Socks and Bedding on Pain and Quality of Sleep in Subjects With Chronic Foot Pain
TerminatedNot applicableNCT00458497
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This study is designed to assess the effects of socks and bedding materials on foot pain, the level of blood oxygen existing in the feet and quality of sleep in subjects who have chronic foot pain from either diabetic neuropathy or other conditions, e.g., peripheral arterial disease, regenerative joint disease). The three main hypotheses to be tested are: 1)compared to placebo socks, subjects wearing Holofiber socks experience reduction in foot pain, 2)compared to placebo bedding, subjects sleeping in beds lined with a Holofiber mattress pad experience improved quality of sleep and 3) compared to placebo socks, subjects who wear Holofiber socks will have increased blood oxygenation levels in their feet.
Study details
- Official title
- Effect of Holofiber Socks and Bedding on Pain and Quality of Sleep in Subjects With Chronic Foot Pain
- Conditions
- Diabetic Neuropathy
- Arthritis
- Peripheral Arterial Disease
- Plantar Fasciitis
- Interventions
- Device: Holofiber fabric
- Device: PET fabric
- Sponsor
- Southern California Institute for Research and Education
- Collaborators
- Hologenix, LLC
- Start date
- 2007-04
- Primary completion
- 2009-12
- Sex
- All
- Age range
- from 21 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria SUBJECTS WITH DIABETIC NEUROPATHY: * Presence of diabetic neuropathic pain with score of 3 or higher on the McGill Short Form Pain Survey * Presence of sensory neuropathy with monofilament (Semmes-Weinstein) testing, as defined as failure to sense the filament in 2 locations (out of six total) on a least one foot. * Previous diagnosis of diabetes (type II) as well as diabetic neuropathy by a physician * Age greater or equal to 21 Exclusion Criteria SUBJECTS WITH DIABETIC NEUROPATHY: * Presence of significant peripheral arterial disease in either lower extremity (abi greater than 0.9 bilaterally) * Skin ulceration on either foot or limb threat from infection or vascular disease at study enrollment * Inability to comply with study procedures or give informed consent * Women of child bearing potential * Spouse/partner is a women of child bearing potential and you share the same bed * Non-ambulatory status * Inability to comply with study restrictions on changing sleeping or pain medication * Severe psychiatric or medical disorder that would affect compliance * Known allergy to PET or Dacron Inclusion Criteria SUBJECTS WITHOUT DIABETIC NEUROPATHY: * Chronic foot or angle pain with a score of 3 or higher on the McGill Short Form Pain Scale * Absence of sensory neuropathy with monofilament (Semmes-Weinstein) testing, as defined as ability to sense the filament in 6 locations (out of 6 total) on both feet * The presence of a condition that causes chronic foot pain such as arthritis, peripheral arterial disease, plantar fasciitis, or other conditions not related to diabetic neuropathy, previously diagnosed by a health care provider * Age greater to or equal to 21 Exclusion Criteria SUBJECTS WITHOUT DIABETIC NEUROPATHY: * Presence of significant peripheral arterial disease in either lower extremity (abi less than or equal to 0.5 in either extremity) * Skin ulceration on either foot or limb threat from infection or vascular disease at study enrollment * Inability to comply with study procedures or give informed consent * Women of child bearing potential * Spouse/partner is a women of child bearing potential and you share the same bed * Non-ambulatory status * Inability to comply with study restrictions on changing sleeping or pain medication * Severe psychiatric or medical disorder that would affect compliance * Previous diagnosis of neuropathy affecting lower extremities * Known allergy to PET or Dacron
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00458497